1. Medtech Insight
  2. >>Business
  3. >>R&D
  4. >>Clinical Trials

Axogen Seeks FDA Approval For Avance Nerve Graft

 
• By Reed Miller

Supported by results from the RECON trial, the Florida company will file a biologics license application for its Avance nerve graft used surgical repair of finger injuries

Avance Nerve Graft Circle
AXOGEN'S AVANCE NERVE GRAFT • Source: Axogen Inc.

Axogen is on track to seek US Food and Drug Administration approval for its Avance nerve graft device by the end of next year.

Avance is a biologically active, “off-the-shelf,” decellularized human nerve allograft that bridges severed peripheral nerves. It provides “structural guidance” to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

More from R&D

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Opinion: Catch A Fraudulent Scientist -- If You Can

 
• By Ivor Campbell

As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.